NCT00909077

The Efficacy of Dexamethasone Versus Dexamethasone Combined With Rituximab in Patients With Newly Diagnosed Idiopathic Thrombocytopenic Purpura (ITP)

A Randomised Phase III Study of the Efficacy of High Dose Dexamethasone Versus High Dose Dexamethasone in Combination With Rituximab (MabThera®)in Patients With Newly Diagnosed Idiopathic Thrombocytopenic Purpura (ITP)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Copenhagen University Hospital at Herlev · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this study we want to investigate if combination therapy with rituximab (R) + dexamethasone (DXM) is superior to monotherapy with DXM in patients with newly diagnosed idiopathic thrombocytopenic purpura (ITP). Before treatment molecular studies - gene expression profiling - are performed to characterize at the molecular level those patients responding adequately to the treatment as compared to those obtaining a minor or no responses. The hypothesis is that combination therapy is superior to monotherapy as defined above. Using gene expression studies up-front the hypothesis is that this method may be able to predict the response to treatment.

Conditions

• Idiopathic Thrombocytopenic Purpura

Interventions

Type	Name	Description
DRUG	Dexamethasone	Dexamethasone tablets: 40 mg/day for four days
DRUG	Dexamethasone and Rituximab	Dexamethasone tablets: 40 mgs/day for four days Rituximab iv 375 mg/m\^2 weekly, a total of four times. Administered on day 2 (i.e. the patient has been treated with Dexamethasone for one day)

Timeline

• Start date: 2004-08-01
• Primary completion: 2012-06-01
• Completion: 2017-08-01
• First posted: 2009-05-27
• Last updated: 2019-09-10

Locations

10 sites across 1 country: Denmark